Drugmakers oppose measure to facilitate generic-drug development | Senate bill would add reporting requirements to 340B program | Drug lobby says compulsory licensing threatens Colombia's OECD membership
January 17, 2018
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Drugmakers oppose measure to facilitate generic-drug development
Drugmakers are lobbying Congress not to include language in a long-term spending bill that would prevent makers of branded drugs from withholding samples from generic-drug makers.
The Hill (1/17) 
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Legislative & Regulatory News
Senate bill would add reporting requirements to 340B program
A bill sponsored by Sen. Bill Cassidy, R-La., would require hospitals to report both revenue derived from participation in the 340B drug discount program and demographics on patients who receive drugs covered by the program.
Politico Pro (subscription required) (1/23) 
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Drug lobby says compulsory licensing threatens Colombia's OECD membership
Pharmaceutical Research and Manufacturers of America asked Colombia's health department to revoke a resolution capping prices on hepatitis C treatments and moving toward issuing compulsory licenses and said failure to do so could undermine a trade agreement with the US and Colombia's efforts to join the Organization for Economic Cooperation and Development.
STAT (tiered subscription model)/Pharmalot (1/16) 
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House Republicans push cost-sharing reductions, reinsurance
House Republicans leaders are attempting to advance a bill designed to fund cost-sharing reduction payments and a reinsurance pool. The bill will likely face opposition, however, with Democrats having largely abandoned support for CSRs after the repeal of the Affordable Care Act's individual mandate penalty, and many Republicans are opposed.
Modern Healthcare (tiered subscription model) (1/16) 
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FDA will release more post-approval data on some drugs
The FDA will release clinical study summary reports for recently approved drugs under a pilot program that is part of new transparency initiatives by the agency, Commissioner Scott Gottlieb said.
The Washington Post (tiered subscription model) (1/16),  Regulatory Focus (1/16) 
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Drug Industry Spotlight
Merck reports positive results from Keytruda lung cancer study
Keytruda along with two chemotherapies extended disease-free progression of lung cancer in a clinical trial, Merck announced.
Reuters (1/16) 
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PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 266 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.

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